Cyberknife System

• • Terminated Z-0865-2017 FDA Class II ·initiated 6 Dec 2016

  Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife Robotic Radiosurgery System.

• • Terminated Z-2014-2010 FDA Unclassified (pre-2012) ·initiated 26 May 2010 ·on shared 510(k) K011024

  The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K011024 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• The Cyberknife System for Stereotactic Radiosurgery/ Radiotherapy V2.1

  Class II

  FDA 510(k) K000478 Active Cleared 19 Apr 2000

• Modification to Cyberknife Robotic Radiosurgery System

  Class II

  FDA 510(k) K091146 Active Cleared 1 May 2009

• Cyberknife System for Sterotactic Radiosurgery/Radiotherapy

  Class II

  FDA 510(k) K032345 Active Cleared 3 Sep 2003

• Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

  Class II

  FDA 510(k) K041315 Active Cleared 10 Jun 2004

• Cyberknife Robotic Radiosurgery System

  Class II

  FDA 510(k) K062967 Active Cleared 30 Oct 2006

• The Cyberknife System for Stereotactic Radiosurgery/Radiotherapy

  Class II

  FDA 510(k) K984563 Active Cleared 14 Jul 1999

See all devices from Accuray, Inc. →